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Completed

NCT Number: NCT03953651

Clinical Presentation and Outcomes in Patients at Risk of Type II Myocardial InfarctioN in the emerGency Department.

Type 2 myocardial infarction has been reported in the Universal Definition of Myocardial Infarction for more than 10 years and most studies resulted in a high mortality rate. However, little to nothing is known for both criteria to define myocardial oxygenation imbalance threshold and the outcome of these patients presenting with myocardial oxygenation imbalance.

The aim of this study is to compare the outcome at 6 months for patients admitted in the emergency department with a myocardial oxygenation imbalance, depending on whether a type 2 myocardial infarction occured or not.

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Key information

Conditions

Myocardial Oxygenation Imbalance Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Edouard Herriot

Lyon, 69003, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age 18 years old or older ;
  • At least one condition of myocardial oxygenation imbalance :
  • Oxygen saturation below 90% ;
  • Haemoglobin level below 130 grams/Liter (g/L) for men, 120 g/L for women ;
  • Persistent heart rate over 110 beats per minute, for more than 20 minutes ;
  • Persistent systolic blood pressure below 90 millimeters of mercury (mmHg) for more than 20 minutes despite fluid resuscitation ;
  • Persistent systolic blood pressure over 180 mmHg for more than 20 minutes.

Exclusion criteria

  • Patient admitted with type 1 myocardial infarction ;
  • Patient presenting a condition for Non Ischemic Myocardial Infarction (pulmonary embolism, acute stroke, acute kidney failure, etc…)
  • Patient who declines to participate;
  • Pregnant or breastfeeding women ;
  • Patient deprived of liberty (inmate, administrative protection)

Treatment and study plan

Follow-up

Other

Onset of Major Adverse Cardiovascular Event of death from all causes will be collected at 3 and 6 months after inclusion.

Primary outcomes

  1. Onset of a Major Adverse Cardiovascular Event at 6 months

    Time frame: 6 months

    Onset of a Major Adverse Cardiovascular Event such as:

    • Cardiovascular death
    • Non fatal myocardial infarction
    • Admission for acute heart failure
    • Non fatal stroke

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: COMING

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 16, 2019
Registry last updated
Jul 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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